We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00669448
Previous Study | Return to List | Next Study

A Pilot Trial on Effect of Mindfulness-based Cognitive Therapy for Individuals With Multiple Chemical Sensitivities (MCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00669448
Recruitment Status : Completed
First Posted : April 30, 2008
Last Update Posted : August 19, 2011
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

OBJECTIVES

The objective is to evaluate the effect of an 8-week mindfulness-based cognitive therapy (MBCT) programme on psychological - and somatic symptoms, and illness perceptions in individuals with self- reported multiple chemical sensitivities.

PARTICIPANTS

Participants will be recruited among respondents to a survey on the consequences of self-reported symptoms related to inhalation of airborne chemicals conducted by the Danish Research Centre for Chemical Sensitivities.

DESIGN

The pilot trial is designed as a randomized trial on the effect of MBCT versus treatment as usual.

INTERVENTION

The MBCT programme includes 2½ hours of group training at the Psychiatric Centre, Rigshospitalet once a week for 8 weeks. Furthermore participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course.

OUTCOME MEASURES

Effect of MBCT will be estimated from individual scores on psychometric scales


Condition or disease Intervention/treatment Phase
Multiple Chemical Sensitivities Behavioral: Minfulness-based cognitive therapy Not Applicable

Detailed Description:

BACKGROUND

Multiple chemical sensitivities is a collective term used to describe illness from exposure to common environ-mental agents. A recent Danish population-based cross sectional study reported that 27% of the respondents reported various symptoms from exposure to common environmental agents. In 19% of the respondents symptoms had led to behavioral changes and in 3.3% of the respondents to adjustments in either social life or occupational conditions, and in 0.5% to adjustments in both social life and occupational conditions. Multiple chemical sensitivities is not acknowledged as a clinical diagnose in Denmark and the Danish Healthcare System has no clinical guidelines for management of people who report this type of illness.

OBJECTIVES

To evaluate the effect of an 8-week mindfulness-based cognitive therapy (MBCT) programme on psychological - and somatic symptoms, and illness perceptions in individuals with self- reported multiple chemical sensitivities.

PARTICIPANTS

Participants will be recruited among respondents to a survey on the consequences of self-reported symptoms related to inhalation of airborne chemicals conducted by the Danish Research Centre for Chemical Sensitives.

DESIGN

The pilot trial is designed as a randomized trial on the effect of MBCT versus treatment as usual. Eligible participants (n= 42) stratified by occupational status (e.g. employed/not employed) will be randomized to either intervention (MBCT) or treatment as usual.

INTERVENTION

The MBCT programme includes 2½ hours of group training at the Psychiatric Centre, Rigshospitalet once a week for 8 weeks. Furthermore participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course.

OUTCOME MEASURES

Effect of MBCT will be estimated from individual scores on the following psychometric scales: Symptom-Check List-92, The Brief Illness Perception Questionnaire, Perceived Stress Scale-10 and The Subjective Health Complaints-inventory. Estimations will be carried out at baseline, four weeks after start of MBCT programme, eight weeks after start of MBCT programme, and three months after ending the MBCT programme.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial on the Effect of Mindfulness-based Cognitive Therapy Versus "Treatment as Usual" for Individuals With Multiple Chemical Sensitivities
Study Start Date : April 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Behavioral: Minfulness-based cognitive therapy
    Mindfulness Based Cognitive Therapy (MBCT) is a group intervention that integrates elements from primarily Mindfulness-based Stress Reduction programme (MBSR)and cognitive therapy.The MBCT programme includes 2½ hours of training once a week for 8 weeks. In addition participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course.

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Symptom Checklist- 92 (SCL-92) [ Time Frame: Baseline, four - and eight weeks after start of MBCT course, 3 months after ending MBCT course ]

Secondary Outcome Measures :
  1. Perceived Stress Scale (PSS-10) [ Time Frame: Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course ]
  2. The subjective health complaints (SHC) inventory [ Time Frame: Baseline, four- and eight weeks after start of MBCT course, 3 months after ending MBCT course ]
  3. The Brief Illness Perception Questionnaire (Brief IPQ) [ Time Frame: Baseline, four - and eight weeks after start of MBCT course, three months after ending MBCT course ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years,
  2. Currently living in Zealand,
  3. Self - reported adjustments of social life and/or occupational conditions due to symptoms related to inhalation of airborne chemicals,
  4. Registered at the Danish Research Centre for Chemical Sensitivities because of self-reported symptoms attributed to common chemical scents,
  5. Consulted the Al-lergy Clinic,
  6. Rigshospitalet between 1990 and 2006 because of self-reported symptoms related to exposures to common environmental agents,
  7. Informed consent

Exclusion Criteria:

  1. Severe depression
  2. Psychotic disorders
  3. Medical treatment with antianxiety agents and antidepressants
  4. Alcohol - or drug abuse
  5. Previous participation in a MBCT programme
  6. Lack of informed consent
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669448


Locations
Layout table for location information
Denmark
The Danish Research Centre for Chemical Sensitivities
Gentofte, Denmark, 2820
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Sine Skovbjerg, cand.san The Danish Research Centre for Chemical Sensitivities
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: The Danish Research Centre for Chemical Sensitivities, University Hospital, Gentofte
ClinicalTrials.gov Identifier: NCT00669448    
Other Study ID Numbers: ID H-C-2007-0088
H-C-2007-0088
First Posted: April 30, 2008    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: April 2008
Keywords provided by University Hospital, Gentofte, Copenhagen:
Multiple chemical sensitivities
MCS
Mindfulness-based cognitive therapy
MBCT
 Behavioural intervention
Stress
Illness perceptions
Pilot trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Multiple Chemical Sensitivity
Immune System Diseases
Environmental Illness
Disorders of Environmental Origin